The Recall Desk

Hazard

False Susceptible Result recalls

5 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
5
Critical
0
Severe
4
Most recent
2024-10-16

Of the 5 false susceptible result recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (80%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all false susceptible result recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–5 of 5

  • HighFDA (Devices)·Z-0026-2025·2024-10-16

    BD Synapsys Laboratory Software May Display Incorrect Antibiotic Susceptibility Results

    BD Synapsys Informatics Solution versions 4.20–5.30 contain a software error that may incorrectly display antibiotic susceptibility results, potentially leading to inadequate or prolonged antibiotic treatment.

    Product
    BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0332-2023·2022-12-14

    FDA Class I Recall: Thermo Sensititre Gram Negative Diagnostic Test Inaccuracy

    Thermo Scientific Sensititre CMC7AFLF Gram Negative diagnostic tests may produce false susceptible results for certain bacteria, potentially leading to ineffective antibiotic treatment decisions. The FDA has classified this as a Class I recall.

    Product
    Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0327-2023·2022-12-14

    Thermo Sensititre diagnostic plate recalled for false susceptibility results

    Sensititre diagnostic plates may give false antibiotic susceptibility results for certain bacteria species, potentially affecting treatment decisions. The FDA issued a Class I recall for approximately 1,917 units distributed nationwide.

    Product
    Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0328-2023·2022-12-14

    Medical Device Recall: Sensititre GN6F May Report False Antibiotic Susceptibility Results

    The FDA recalled Sensititre GN6F Gram Negative antimicrobial susceptibility test plates (2,471 units) because they may report false results indicating bacteria are susceptible to certain antibiotics when they are actually resistant.

    Product
    Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
    Category
    Medical Device
    Distribution
    Distributed nationwide